Cleared Traditional

K070984 - THE PRECISION / OPTIUM POINT OF CARE BL...

K070984 is an FDA 510(k) clearance for THE PRECISION / OPTIUM POINT OF CARE BL..., manufactured by Abbott Diabetes Care, Inc.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K070984 · Abbott Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
209d
Days
Class 2
Risk

K070984 is an FDA 510(k) clearance for the THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on November 1, 2007 after a review of 209 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Diabetes Care, Inc. devices

FDA 510(k) Submission Details - K070984

510(k) Number K070984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date November 01, 2007
Days to Decision 209 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 88d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LFR Glucose Dehydrogenase, Glucose

All 55
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K070984.
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
K092688 · Taidoc Technology Corporation · Jul 2011
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
K101037 · Eps Bio Technology Corp. · May 2011
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
K083223 · Abbott Diabetes Care, Inc. · Apr 2009
MODIFICATION TO ACCU-CHEK GO SYSTEM
K051592 · Roche Diagnostics Corp. · Sep 2005
ACCU-CHEK INTEGRA SYSTEM
K050872 · Roche Diagnostics Corp. · May 2005
ACCU-CHEK AVIVA SYSTEM
K043474 · Roche Diagnostics Corp. · Apr 2005